None listed
Conditions
Interventions
Intervention1: Xerina DS (D3034(R4)): Patch application as per BIS standard.0.04 ml or 40 microlitre of the products is dispensed in the aluminium chambers of the patch and applied on the back of the
Sponsors
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Healthy Human Subjects 2) Skin should be healthy on the studied anatomic unit
Exclusion criteria
Exclusion criteria: 1. For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2. Having refused to give his or her assent by not signing the consent form 3. Taking part in another study liable to interfere with this study 4. Being diabetic. 5. Being asthmatic. 6. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). 7. Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin). 8. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 9. Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months. 10. Having changed his or her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 11. The day of the patch application: no cosmetic product must be used (test site clean with water only).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitization potentialTimepoint: Day 3, Day 5, Day 7, Day 10, Day 12, Day 14, Day 17, Day 19, Day 21, Day 38, Day 39, Day 40 | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed